Facultad de Farmacia, Universidad de La Laguna, La Laguna 38206, Spain; Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna, La Laguna 38206, Spain; Programa de Doctorado en Ciencias Médicas y Farmacéuticas, Desarrollo y Calidad de Vida, Universidad de La Laguna, 38200 La Laguna (Tenerife), Spain; Programa predoctoral de formación del personal investigador en Canarias, Consejería de Economía, Conocimiento y Empleo, Spain.
Facultad de Farmacia, Universidad de La Laguna, La Laguna 38206, Spain; Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna, La Laguna 38206, Spain.
Int J Pharm. 2021 Aug 10;605:120854. doi: 10.1016/j.ijpharm.2021.120854. Epub 2021 Jul 3.
3D printed pharmaceuticals offers the potential to manufacture personalized medicines for patients. Such technology is of particular benefit to pediatric populations from the offer of increased patient compliance and dose flexibility. With a bench-to-patient approach, this study established and optimized the critical parameters of the semi-solid micro-extrusion 3D printing process to guarantee the quality attributes of the final dosage form. Pediatrics orodispersible printlets of hydrochlorothiazide were manufactured through the modification of printing parameters, as well as printing surfaces materials. The printlets were characterized and the dimensions were measured using a digital caliper and computer vision algorithm. This study identified that the printing surface material and the first printing layer are critical parameters for high-resolution printlets. Following the optimization of 3D printing parameters, high quality orodispersible printlets loaded with hydrochlorothiazide - specifically tailored for pediatric patient's dosage forms - were obtained (4.62 mm × 1.90 mm). Mass and content uniformity assays demonstrated that the printlets satisfied the requirements for orodispersible printlets set by the European Pharmacopoeia. As such, in order to transition from laboratory research towards the treatment of patients, distinguishing accurate 3D printing parameters is necessary for the manufacture of medicines with key quality attributes that follow Pharmacopoeia requirements.
3D 打印制药为患者提供了制造个性化药物的潜力。这种技术对儿科患者特别有益，因为它提高了患者的依从性和剂量灵活性。本研究采用从实验室研究到患者治疗的方法，通过对关键参数的建立和优化，保证了最终剂型的质量属性。通过对打印参数和打印表面材料的修改，制造了氢氯噻嗪儿科口溶打印片。采用数字卡尺和计算机视觉算法对打印片进行了表征和尺寸测量。本研究确定，打印表面材料和第一层是获得高分辨率打印片的关键参数。通过对 3D 打印参数的优化，获得了载有氢氯噻嗪的高质量口溶打印片——专门为儿科患者的剂型设计（4.62 毫米×1.90 毫米）。质量和含量均匀度检测表明，打印片符合欧洲药典对口溶打印片的要求。因此，为了从实验室研究过渡到患者治疗，需要准确区分 3D 打印参数，以制造符合药典要求的具有关键质量属性的药物。
